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Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

NCT01495039 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2017-04-05

No results posted yet for this study

Summary

Purpose. Oral chemoprophylaxis has been advocated to reduce the incidence of Candida colonization and infection. However, Candida prophylaxis in intensive care unit (ICU) is still a matter of debate.

Methods. Randomized, single-center trial studying single drug (nystatin) versus control in surgical ICU patients. Multiple-site testing for fungi were performed in each patient at ICU admission (T0) and subsequently every 3 days (T3, T6, T9…). The primary evaluation criterion was the time course of colonization index (CI) during ICU stay.

Conditions

  • Fungal Prophylaxis
  • Candida Infection
  • Critical Illness
  • Surgery

Interventions

DRUG

Nystatin

Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube)

Sponsors & Collaborators

  • Policlinico Hospital

    lead OTHER

Principal Investigators

  • Francesco Bruno, Professor · University of Bari

  • Filomena Puntillo, Professor · University of Bari

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-08-31
Completion
2010-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01495039 on ClinicalTrials.gov